Researchers participating in the Blueprint Neurotherapeutics Network for Biologics receive grant funding (a UG3/UH3 award or U44 award if a small business) and no-cost access to biotherapeutic development consultants and contract research organizations (CROs).
Research Grants (UG3/UH3 or U44)
All projects that enter BPN-Biologics begin with a UG3 phase (or U44 Phase I) of up to two years, which should be used to complete all lead optimization activities (for Discovery-stage projects) or any additional preparatory activities needed to initiate IND-enabling studies (for Development-stage projects). This phase will also be used to engage the LDT in establishing a detailed research plan and go/no-go milestones for all subsequent work.
Projects can enter BPN-Biologics during the Discovery or Development stage and may seek support through phase I/first-in-human testing. Discovery involves biologic agent characterization and optimization in order to identify a suitable development candidate. During the Development stage, a candidate undergoes preclinical toxicology testing required for an IND and manufacturing, ultimately advancing to phase I/first-in-human testing. BPN-Biologics-supported Development activities include chemical manufacturing and controls (CMC), formulation development, toxicology studies, regulatory support, and phase I/first-in-human testing.
Each Lead Development Team receives support from BPN-Biologics consultants. Consultants are assigned to a project with considerations for the project team's individual needs and consultants' expertise.
Contract Research Organizations
BPN researchers receive no-cost access to the network's Contract Research Organizations (CROs). LDTs plan and coordinate studies conducted by BPN CROs.
Collaborative Drug Discovery - data management
Duke University School of Medicine - clinical trials
PPD - clinical trials
SRI International - in vivo PK and Toxicology
Example Target Product Profiles: Target Product Profile (TPP)(pdf, 189 KB)
Example Agent Profiles: